Cleanroom Fill Technicians (All Shifts)

Fagron Nederland BV; Wichita (KS); On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

401(k) with match

Medical, vision and dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron US is seeking a Cleanroom Fill Technician to assemble finished sterile products with strict emphasis on patient safety and product quality. The role ensures ongoing cleanliness of the cleanroom, proper garbing, and accurate documentation.

You will follow CGMP guidelines, validate equipment, and support production through accurate batch records and timely preparation of sterile components. Strong attention to detail and teamwork are essential in this role.

Qualifications

• Requires high school diploma or equivalent with 1–4 years in hospital or manufacturing aseptic filling.
• Knowledge of cleanroom procedures preferred but not required.
• Familiarity with CGMP guidelines preferred but not required.
• Must pass validation three consecutive times and re-qualify every 6 months.
• Strong attention to detail and accuracy in sterile technique and documentation.

Responsibilities

• Maintain a sterile environment in the cleanroom, garb, and follow cleanroom procedures per CGMP guidelines.
• Clean equipment daily and ensure validations are up to date.
• Oversee co-workers through the "tech check tech" process for aseptic filling and documentation.
• Take inventory to identify components needed for production batches.
• Ensure all components entering the cleanroom are sterile.

Skills

Attention to detail

Aseptic technique

Teamwork

Documentation

Quality compliance

Education

High school diploma

Job description

About The Job

The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensure that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked.

Key Responsibilities

• Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines.
• Cleans the equipment in the cleanroom daily; ensures equipment validations are up to date.
• Follows the “tech check tech” process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
• Take inventory into the cleanroom to identify components needed to fill production batches, as scheduled.
• Ensure all components entering the clean room are sterile.
• Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room.
• Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
• Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.
• Validates that garbing standards have been followed on a semi-annual basis.
• Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months.
• Follows standard operation procedures to package sterile products in their final container closure.
• Designate people and hoods for different tasks.
• Use appropriate process to establish sterility on products received via pass through from compounding.
• Clock in and out for every scheduled shift in a timely manner.

Basic Qualifications

• High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling.
• Knowledge of cleanroom procedures preferred but not required.
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations preferred but not required.
• Must pass validation three consecutive times before handling product in clean room; must be re-qualified every 6 months with a minimum requirement of filling a set minimum of syringes and vials in an established time frame and difficult operation conditions. Preferred but not required.
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.

Working Conditions

• This position requires standing, walking, and bending for extended periods of time.
• Employees must wear specialized protective clothing—commonly referred to as “gowning” or “garb”—to minimize the risk of contamination.
• Pushing and pulling carts loaded with totes of product.
• The employee must occasionally lift and/or move totes of product weighing over 40 pounds. Team lifting is strongly encouraged.
• The employee will be required to read small print.
• Regular exposure to strong chemical odors and fumes.
• Work may be performed in confined or tight spaces.
• Moderate to high noise levels from machinery and surrounding personnel.
• Use of appropriate personal protective equipment (PPE) is required.

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready For The Challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.